MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL PLATE FB SZ 1 LT

Model Number 350-11-01

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 12/30/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.No information provided in the following section(s).

Event Description

It was reported that during impaction of the left ankle, the surgeon was trying to further seat the tibial just a bit more after already impacting it several times and a small part of the rim of the implant where the poly inserts into broke off.This prevented a trial poly from being placed in the component and ultimately the surgeon took that tibial tray out and put a new one in its place.There was no surgical delay.Patient was last known to be in stable condition following the event.No other patient information or medical history was reported.Devices will be returning.

Manufacturer Narrative

Pending evaluation.No information provided in the following section(s).

Event Description

It was reported that during impaction of the left ankle, the surgeon was trying to further seat the tibial just a bit more after already impacting it several times and a small part of the rim of the implant where the poly inserts into broke off.This prevented a trial poly from being placed in the component and ultimately the surgeon took that tibial tray out and put a new one in its place.There was no surgical delay.Patient was last known to be in stable condition following the event.No other patient information or medical history was reported.Devices will be returning.

Manufacturer Narrative

Section h10: (h3) the prosthesis fracture reported was likely the result of not using the tibial protector as instructed in the operative technique when impacting the tibial plate.

• Brand Name: VANTAGE
• Type of Device: TIBIAL PLATE FB SZ 1 LT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13290666
• MDR Text Key: 285424319
• Report Number: 1038671-2022-00030
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862276131
• UDI-Public: 10885862276131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 350-11-01
• Device Catalogue Number: 350-11-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female